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Virtual Reality: The New Game In Mental Health Care To Improve Outcomes

Virtual reality is seeing an upsurge in use by mental health practitioners for treating conditions such as post-traumatic stress disorder, panic disorders and anxiety in a safe and controlled manner. With the advent of affordable VR headsets and technological advances, companies and researchers worldwide are seizing on the opportunity to bring such techniques as VR exposure therapy and cognitive behavioral therapy to telemedicine, specialty clinics and directly to consumers to improve outcomes and better lives.

Neurology Innovation Market Intelligence

EU's MDR: When Three Plus Four Does Not Necessarily Make Seven

Companies hoping to keep their medtech products certified under the current Medical Devices Directive on the market until May 2024 need a reality check, experts say. Things may not be as they seem.

Medical Device Europe Regulation

RepliCel Poised To Partner Up For Precision-Control Dermal Injector

RepliCel Life Sciences is set to unveil in July the first functioning prototype of its next-generation dermal injector, which the company said has already sparked the interest of big dermal filler manufacturers. While the technology had been developed originally to deliver RepliCel's cell therapies for pattern baldness and aging or sun-damaged skin, the company believes the injector's unique features – including electronically-controlled dosing and delivery – allow it to be used in myriad applications.

Dermatology Regenerative Medicine Companies

Device Week – June 23, 2017

On this week's Medtech Insight podcast: US congressional hearing highlights India’s efforts to place price caps on foreign-made devices; Senate health-care bill nixes device tax; Costa Rican quality control experts lean on each other for industry education; US FDA issues a draft guidance on electronic records and signatures.

FDA Quality Costa Rica

Recent Tweets from Medtech Insight

Policy & Regulation Explore this Topic

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Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

In Vitro Diagnostics Personalized Medicine Regulation

Compliance Corner: Keep 'ALCOA' In Mind To Ensure Quality Data Integrity, Says US FDA Expert

When inspecting a device manufacturing facility, FDA investigators will check a company's quality data to make sure it's Attributable, Legible, Contemporaneous, Original and Accurate – or "ALCOA," the agency's national device expert says.

Quality Control Compliance Medical Device

CMS Proposes High Payment Score For Use Of Imaging Appropriate-Use Criteria

In a proposed rule, the US Medicare agency said clinicians may count use of advanced imaging appropriate use criteria (AUC) through clinical decision support as a new and highly-weighted portion of an overall score to win reimbursement through the Merit-Based Incentive Payment System. The move was touted by the imaging industry.

Reimbursement Regulation

China Proposes Local Trial Exemptions For Another 130 IVDs, 27 Devices

China has proposed expanding its list of IVDs and medical devices that are exempted from the requirement to undergo local clinical trials. The proposal, when finalized, may speed up the registration of affected products by several months. With respect to ongoing trials, manufacturers will have to decide whether they want to continue with these.

Clinical Trials Regulation

US Trade Rep May Take Enforcement Actions Against India Over Device Price Controls

US Trade Representative Robert Lighthizer told Senate Finance Committee Chairman Orrin Hatch, R-Utah, that if India's ongoing practices to impose price controls on US device imports continue, he would consider "enforcement actions," if India's actions violated any World Trade Organization trading rules.

Cardiology Trade

Warning Letter Roundup & Recap – June 20, 2017

US FDA did not release any device-related warning letters the week of June 20.

Device Warning Letters Medical Device

South African Medtech Reg: Pieces Coming Together, As August Deadline Approaches

South African medtech firms have been given until August 24 to license their business establishments and list (but not actually register) their products. There is controversy over the fees and a growing list of tasks for industry and the government, but the key pieces generally seeming to be falling into place to support standing up a South African medtech regulatory system.

South Africa Regulation

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Regulation Clinical Trials

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says

Manufacturers that don't consider all possible dangers their products can pose to consumers is a growing problem, FDA's national expert on devices says. Phil Pontikos also is worried that firms aren't putting their best foot forward when using risk assessment tools.

Risk Management Compliance

As Device Firms Take Costa Rica By Storm, Quality Control Experts Champion 'Pura Vida'

"Pura Vida" – a Spanish phrase meaning the "pure" or "simple life" – isn't just the unofficial motto of Costa Rica; rather, it's a state of mind, locals say. But as more and more medical device manufacturing facilities pop up in the tiny Central American nation, quality assurance professionals there have discovered that ensuring top-notch product quality doesn't necessarily make life simpler. To jump that hurdle, QA experts from a variety of firms – including Medtronic, Precision Concepts and Creganna Medical – have banded together to lean on each other as they search for solutions to quality systems issues, as well as knowledgeable input on hot quality and compliance topics.

Quality Control Compliance

Zimmer Biomet Resolves Chinese Plant Warning Letter

The warning letter referred to CAPA and quality assurance issues at a surgical instruments manufacturing plant in China.

Quality Control Orthopedics

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Philips Completes M&A Hat Trick With Neurodiagnostic Buy

In its third acquisition this year so far, Philips is buying neurodiagnostic firm Electrical Geodesics.

Neurology Diagnostics M & A

Latest From Commercial

Calcivis Ready To Sink Teeth Into UK Market With Imaging Device

Scottish dental technology specialist Calcivis is gearing up for a UK launch of its tooth imaging device. The Edinburgh-based company has developed the Caries Activity Imaging System which can detect calcium deficiencies in tooth enamel that could signal the onset of cavities and thus inform preventive treatment decisions.

Dental Oral StartUps and SMEs

Bonesupport Cements Funding With SEK 500m IPO

Swedish orthobiologics company Bonesupport has closed its initial public offering on the Nasdaq Stockholm exchange, raising SEK500m ($57m) from retail and institutional investors.

Orthopedics Financing

UK Medtech Upscales International Plans Ahead of Brexit

As the UK prepared to leave the EU, the local medtech industry, represented by the Association of British Healthcare Industries, has been busy finding ways to make up for any potential restrictions on market access and business development. On June 21, it announced a three-year growth plan, as explained by ABHI managing director of international Paul Benton in this Medtech Insight podcast interview.

United Kingdom Brexit

Stryker Doubles Down On Novadaq To Boost Medsurg

Stryker is set to expand its surgical offerings after signing a $701m deal to buy Novadaq Technologies, a leading developer of fluorescence surgical imaging technology. The acquisition price is a 96% premium over Novadaq's June 16 closing price, which, according to analysts, is believed to be due to a competitive bidding process for the company.

M & A Surgery

Olympus Settles Power Morcellation Suit

The company was sued by a Georgia woman who said the surgical tool allowed uterine cancer to spread throughout her abdomen. Terms of the settlement were not disclosed.

Legal Issues Medical Device

Pain Device Firm Sued for Securities Fraud

A venture capitalist who sunk $2m into the manufacturer of a device to treat phantom pain has filed suit, claiming the company was mismanaged and filed false securities statements.

Legal Issues Commercial

Clinical R&D Explore this Topic

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Starts & Stops: Corlife's Decellularized Human Pulmonary Valve Shows Early Promise

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. News about trials of cardiovascular devices, especially novel heart valve replacement technologies, lead this month's edition, covering mid-May through mid-June.

Starts & Stops Clinical Trials Research & Development

Latest From Research & Development

Positive Data Give DePuy Synthes' Attune Further Knee-Up

Results of a study by the Canadian Radiostereometric Analysis Network show that the tibial base of DePuy Synthes' Attune knee replacement achieves stable fixation out to two years and recently announced results from the UK's National Joint Registry show a 98.1% four-year implant survivorship rate with Attune in a "real-world" setting.

Orthopedics Clinical Trials

Device Week – June 16, 2017

On this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticeable increase in 510(k)s; new clinical data releases discussed.

FDA Digital Health

INS 2017: Neuromodulation's Future Features Innovative Power Source, Materials And Treatment Protocols

Neuromodulation technology is advancing at breakneck speed, as physicians, academic, and industry innovators deepen their understanding of the field and learn what works and what doesn't. At the Innovations Day held during the 13th world congress of the International Neuromodulation Society in Edinburgh, Scotland, Medtech Insight highlights the notable new techs that are in the pipeline of emerging companies.

Neurology Innovation

OUS Approvals Analysis: IVDs Lead A Slow Month

Only 10 approvals from outside the US were recorded in May in Medtech Insight's approvals tracker. Half of those were for in vitro diagnostics, including three for companion diagnostic for cancer drugs.

Approvals Innovation

Start-Up Spotlight: LensGen, Eye On The Presbyopia Prize

Restoring the eyes' ability to accommodate and seamlessly focus on near and far objects continues to be the holy grail in ophthalmology. Accommodating intraocular lenses offer one approach to tackle presbyopia and allow patients the possibility of eschewing reading glasses. LensGen is one company going down that road and it successfully raised $21m in series A financing – with major optical lens maker Hoya among its backers – in April to advance its fluid-based accommodating IOL, Juvene.

Ophthalmology Innovation

ASCO 2017: Myriad's MyRisk; Nanobiotix' NBTXR3; Chronix' CNI Test; Sirtex SIR-Spheres; ANGLE’s Parsortix CTC Harvester

Over 30,000 oncologists and other health professionals attended the 2017 American Society of Clinical Oncology annual meeting in Chicago, June 2-6. This year's meeting included several presentations on emerging cancer diagnostic and device treatment strategies, including genetic tests, liquid biopsy systems, radioenhancers, and microspheres intended to improve chemotherapy outcomes.

Cancer In Vitro Diagnostics